Compositions for treating animal diseases and syndromes

ABSTRACT

Various compositions containing transfer factor in combination with nutraceuticals are provided including transfer factor in combination with zinc and essential fatty acids and transfer factor in combination with lactic acid generating bacteria. Also provided are methods for treating animal diseases and syndromes using these compositions.

CROSS-REFERENCE

This application is a continuation-in-part of application Ser. No.09/847,036, filed Apr. 30, 2001 now U.S. Pat. No. 6,506,413.

FIELD OF THE INVENTION

This invention relates to compositions of transfer factor in combinationwith specific nutraceuticals and to the use of these compositions intreating diseases and syndromes.

BACKGROUND OF THE INVENTION

Transfer factor which is produced by leucocytes and lymphocytes aresmall water soluble polypeptides of about eight amino acids and alsoassociated cofactors that stimulate or transfer cell mediated immunityfrom one individual to another and across species. Since transferfactors are smaller than antibodies, they do not transfer antibodymediated responses nor do they induce antibody production. Theproperties, characteristics and processes for obtaining transfer factoror transfer factors are discussed in U.S. Pat. Nos. 4,816,563;5,080,895; 5,840,700 and 5,883,224, the contents of which are herebyincorporated by reference into the present application. Transfer factorpreparations have been demonstrated to contain three types of immunemodulation activities. The inducer and suppressor activities areconsidered general and non-specific resulting in overall enhancement ofimmune responsiveness through interactions with the T-helper andT-suppressor cells.

Transfer factor has been described as an effective therapeutic forHerpes simplex virus (Viza, et al.), a treatment for acne blemishes,U.S. Pat. No. 4,435,384 and as a treatment against C. albicans (Khan etal.). Transfer factor has also been used to treat intestinalcryptosporidiosis in recipients treated with specific transfer factor(McMeeking, et al.). Still, et al. also showed that chicken poxinfections were prevented by pretreatment of children treated withtransfer factor from individuals that had chicken pox or who in otherwords had been sensitized to the varicella antigen. The antigen specifictransfer factors are the most well studied and have been demonstrated tobe able to convey the antigen recognition ability of the experienceddonor to the naive recipient. It may be assumed that the individual oranimal that is the source of the transfer factor has been sensitized tothe antigen of interest. The term antigen is defined herein is anythingthat will initiate the cell mediated immune response. However, transferfactor as found in commercial bovine colostrum extract coming from apool of animals (e.g., cows) contains the acquired immunity from all ofthe pool and therefore provides a type of generalized adoptive transferof immunity. Transfer factors or transfer factor can be obtained from adialyzable extract of the lyzed cells or from an extract ofextracellular fluid containing transfer factor. Common sources oftransfer factors are colostrum, ova, blood and milk. It is commonpractice to refer to preparations that contain transfer factor by thename of the active component (i.e., transfer factor or TF). Transferfactor extract containing transfer factors is also herein referred to astransfer factor. Transfer factor from bovine colostrum extract isdefined as defatted water soluble material from colostrum that will passthrough a nominal 10,000 molecular weight filter. The colostral derivedtransfer factor has been prepared with activity against variousorganisms including infectious bovine rhinotracheitis virus. One of thespecific effects of transfer factor is a significantly increased naturalkiller (NK) cell activity. Natural killer cells provide protectionagainst viruses as part of the innate immune defense system.

The use of nutraceuticals to treat vitamin and mineral deficiencies iswell known. However, the use of nutraceuticals, such as vitamins,minerals and other nutritional components to prevent and treat diseasesother than those caused by the deficiency of those nutraceuticals,though still controversial, is receiving more consideration from bothlaymen and physicians. The following is a list of nutraceuticals andsome of their generally acknowledged nutritional and health benefits.

Vitamin A—is important in preventing eye epithileol disorders;deficiency results in night blindness

Vitamin B₂—is essential to human nutrition relating to the oxidation ofcarbohydrates and amino acids

Mixed tocopherols—are antioxidants

Choline Chloride—is a member of the vitamin B complex and a dieteticfactor for furnishing free methyl groups for transmethylation

Vitamin B₆—functions in the formation and breakdown of amino acids andis involved in the synthesis of serotonin and norepinephrine. However,exact dietary requirements are uncertain

Vitamin B₁₂—is an antipernicious-anemia factor essential for normalhemopoiesis

Vitamin E—is an antioxidant that protects against free radicals.

Vitamin K—is essential for the formation of prothrombin

Biotin—functions in metabolic processes leading to the formation of fatsand utilization of carbon dioxide

Folic Acid—a growth factor involved in the formation of nucleic acidsand necessary for the formation of heme

Niacin—a component of the Vitamin B complex, a deficiency results inpellagra

Vitamin D₃—is important in the absorption of calcium

Pantothenic Acid—is considered essential for growth and well being ofanimals; deficiency results in growth retardation, skin lesions andgraying of hair

Thiamine—is necessary in diet of all animals except ruminants; used toprevent beriberi and important in carbohydrate metabolism

Lysine—is an essential amino acid

Methionine—is a sulfur containing essential amino acid

Arginine—is an amino acid important in the synthesis of urea (principalform in which mammals excrete)

Soy—is a source of proteins

Methyl Sulfonyl Methane—is a form of organic sulfur involved in cellmembrane permeability

Zinc—is an essential mineral for growth; deficiency createssusceptibility to various pathogens

Omega 3-, 6-, and 9-Fatty Acids—are essential fatty acids andpolyunsaturated fats; a deficiency results in hypertension and highblood pressure; they are believed to improve immune function

Yeast—(e.g., brewers, bakers, etc.) contains beta glucans which appearto increase production and/or activation of natural killer cells

Calcium—is required for bone development

Phosphorus—is required for bone development

Selenium—a deficiency results in heart muscle disease

Iron—is required for formation of hemoglobin; deficiency results inanemia

Magnesium—is an element required for growth in all living organisms

Manganese—is an element required for growth in all living organisms

Copper—is an element required for growth in plants, animals and mostmicroorganisms

Iodine—is an element necessary for the synthesis of hormone productionby the thyroid gland

Cobalt—is a trace element essential in the nutrition of ruminants(cattle, sheep) and in the maturation of human red blood cells in theform of Vitamin B₁₂

Molybdenum—is a trace element believed to be necessary in animal dietsbut its function in the minimal levels have not been established

Lactic Acid Generating Bacteria—are a digestive aid and growth inhibitorof harmful bacteria

Chrondroitin—is a component of connective tissue which may relieve jointpain and arthritis.

Glucosamine—is a component of micropolysaccharides and glycoproteinwhich may be helpful in arthritis.

Di-methyl glycine—is a methylated amino acid found in all cells and anantioxidant.

Montmorillonite—is collodial clay containing trace elements which areconsidered by some to be important for well being and to compensate forelements no longer in foods because of depleted soils (the componentsare shown below in Table 1)

Super oxide dismutase (SOD)—is an antioxidant enzyme present in themammalian body. It converts super oxide free radicals to the less activeperoxide. It stimulates hair growth and is believed to protect cellsagainst ultraviolet-B irradiation and to protect the heart.

Boswellia—is an herb Boswellia serrata. Boswellic acids, thebiologically active ingredients of the gum resin of this herb, areconsidered to have anti-inflammatory and anti-arthritic actions.

Octocosonol—is derived from wheat germ oil and provides 17% moreresidual energy before fatigue.

TABLE 1 Montmorillonite Components Average Nutrient Content Per Ounce (1Tablespoon = ˜0.36 oz.) (mg) Silicon 6933 Tungsten 0.218 Aluminum Silica2505 Vanadium 0.215 Sodium Chloride 1320 Ruthenium 0.210 Potassium 1293Baron 0.189 Protein 1116 Bromine 0.140 Calcium 1104 Cobalt 0.129 Sulfur431 Selenium 0.110 Iron 431 Syprosium 0.107 Magnesium 224 Fluorine 0.102Chlorine 164 Scandium 0.0997 Titanium 61.9 Samarium 0.0943 Carbon 48.2Nobelium 0.0754 Sodium 37.2 Copper 0.0593 Barium 10.5 Praseodymium0.0539 Phosphate 8.62 Erbium 0.0539 Strontium 6.46 Hafnium 0.0539 Cesium4.93 Ytterbium 0.0377 Manganese 4.04 Lithium 0.0377 Thorium 2.69 Yttrium0.0323 Uranium 2.69 Holmium 0.0296 Arsenic 1.97 Cadmium 0.0296 Chromium1.89 Palladium 0.0189 Molybdenum 1.64 Terbium 0.0161 Nickel 1.62 Thulium0.0161 Iodine 1.28 Gold 0.0161 Lead 1.17 Tantalum 0.0135 Cerium 1.08Iridium 0.0135 Rubidium 0.983 Lutetium 0.0108 Antimony 0.781 Europium0.0108 Gallium 0.673 Rhodium 0.0108 Germanium 0.673 Tin 0.0108 Neodymium0.539 Silver 0.00808 Zinc 0.539 Indium 0.00808 Lanthanum 0.486 Oxygen0.00539 Bismuth 0.385 Mercury 0.00269 Zirconium 0.269 Tellurium 0.00269Rhenium 0.269 Beryllium 0.00269 Thallium 0.269

Allopathic medicine is usually used to treat animal diseases.Unfortunately, such medicines often have serious side effects such asnausea, gastritis, diarrhea, maladsorption of vitamins, circulation andrespiratory problems and allergic reactions. For example, Cushingsdisease, a fairly common physiological abnormality in ungulates,particularly horses, manifests itself as a pituitary adenoma thatresults in erratic cortisol and insulin levels. Cushings syndrome,however, is defined as a cortisol excess regardless of the cause.Clinical signs are frequent urination, polydypsia, failure to shed hairand poor hair coat, lack of muscle tone and sometimes poor coordination.The common allopathic drugs for treating Cushings disease and/orCushings syndrome are Parlodel (bromocreptine mesylate) a dopamineagonist, cyproheptadine a serotonin blocker, and Permax (pergolidemesylate) another dopamine agonist. However, in oral form Parlodel haspoor absorption and the intra molecular injectible form which needs tobe given twice a day is impractical. Cyproheptadine usually takes aboutsix to eight weeks and since it is a serotonin antagonist it can effectother systems in the brain. Permax is also an intense vasoconstrictorand can worsen chronic laminitis which is common with Cushings.

Onchocerciasis is a disease resulting from infection from microfilariaespread by flies and is characterized by fibrous nodules in the skin andsubcutaneous tissues. The usual treatment is the anthelcide Ivermectin,yet the autoimmune component of this disease remains to the extent thatthere are constant relapses. Cortisone and antibiotics are also used.However, both of these drugs can be extremely toxic and often causeallergic reactions. Use of cortisone can also cause a depressed immuneresponse, demineralization and eroding of the sensitive lamina of thehoof wall.

Circo virus is a disease affecting pigeons with a 10% mortality rate.The immune defense of the birds is reduced in a manner similar to thatcaused by an immune deficiency virus or mycoplasma causingsusceptibility to other infections. There are approximately 30,000racing pigeons this disease can affect and known treatments are not veryeffective.

Equine protozoal myelitis that results in severe inflamation of thespinal chord or of the bone marrow is usually treated with Pyrimethamine(an antibiotic), sulfadiazine (an antibiotic) and Trimethoprim sulfur(an antibiotic).

PURRS (porcine upper respiratory and reproductive disease in swine)disease is the most devastating problem in the swine industry costingthe industry millions in loss, from morbidity, mortality, andinfertility in swine. It is usually treated with antibiotics. However,these treatments are costly.

Livestock, especially horses and cows, often suffer from ulcers,including stomach ulcers and ulcerations and inflammation of the joints.The ulcers and ulcerations are usually treated with strong antibioticsand cortisones which again can cause allergic reactions, fever and othersevere side effects. Also, the use of antibiotics to treat animalsespecially livestock food source animals often results in resistance tothose antibiotics which is becoming a serious health problem withrespect to all animals including humans. Inflammation such as laminitisin horses is usually treated with NSAID (non-steroidal antiinflamatorydrug), compositions which again sometimes have serious side effects suchas kidney and liver complications. Use of NSAID compositions such asButazolidin, Banamine, Rymadal, Etogesic and aspirin often cause ulcersin the digestive system allowing toxins from the gut to enter theabdominal cavity and blood stream. This condition is known as leakybowel or gut syndrome and often aggravates the original inflammationthat initiated the treatment. In horses with laminitis, where one istrying to eliminate the flow of toxins to the sensitive lamina in thehorse's hoof wall, the development of leaky gut syndrome is obviouslycounterproductive.

Diseases fairly common in domestic pets are feline leukemia in a cat andflea bite dermatitis in numerous animals such as cats, dogs, etc. Felineleukemia can be treated with various current oncological drugs but theyare very expensive. Treatment of flea bite dermatitis in animals usuallyinvolves antibiotics and prednisone which is often ineffective and useof prednisone can cause sodium retention, eye problems and heartfailure.

Strangles, a disease in horses caused by Streptococcus equi that formsabscesses in the lymph nodes and other parts of the body, is usuallytreated by rest and antibiotic therapy. The disease spreads quickly andis difficult to prevent. The disease can also cause chronic life-longmononucleosis-like symptoms in the horse.

Many animals such as dogs and livestock (horses, cows, sheep, etc.)suffer from chronic coughs believed to be caused by dust allergens.While seldom fatal, the ailment can lead to serious complications suchas secondary infections. The cough which is often confused with otherupper respiratory infections is usually treated with antibiotics such asTrimethoprim sulfur and expectorants. However, such treatment is oftenineffectual.

Lymphopenia and hypothyroidism also occur in livestock. Lymphopenia is adecrease in the number or proportion of lymphocytes in the circulatingblood which often leads to an increased susceptibility to bacterial andfungal infections. This hematologic abnormality can result fromhereditary diseases, impaired production because of bone marrow cancer,but often the result of the impairment of cell production by drugs suchas cancer drugs, antithyroid drugs, phenothyoscenes, penicillin, andother antibiotics. Again, treatment usually involves broad spectrumantibiotic therapy which again can lead to antibiotic resistance orother physiological problems.

Hypothyroidism in livestock and often domestic animals frequently occursfor unknown reasons. Treatment often involves replacement therapy withsynthetic preparations of thyroxine. However, long-term replacementtherapy can result in heart problems and bone diseases such asosteoporosis.

Another very serious problem with farm animals is high morbidity (i.e.,sickness) among young animals which can result in severe financiallosses to farmers and ranchers. The current methods of controllingmorbidity involve a standard oat or grain diet for livestock and fowl,and inoculations and antibiotics.

In young cattle (stockers), this problem is particularly significant.The weaning, processing and transport of stockers is known to be verystressful and often leads to high morbidity and mortality rates due tobovine respiratory disease (BRD). In a six year study over 15% ofstocker cattle exhibited BRD. Approximately 70% of feedlot death lossesare attributable to BRD. Death losses are often not the largest costs.Weight loss, lower daily gain, carcass degradation, medicine costs anddrug residues in the carcass can amount to $50.00-$100.00 per animalwithout death loss.

The observation of clinical signs of BRD and removal of calves was onlypoorly correlated with the presence of lung lesions at the time ofslaughter. On the other hand, the drop in frequency and duration ofeating and drinking are good indicators of BRD, as evidenced by thepresence of lung lesions at time of slaughter. The dry matter feedintake for calves during the first 28 days in the feedlot has been shownto be 32% less in sick calves than in their well counterparts;additionally the average daily weight gain during this period was 0.01Kg (0.02 lbs) vs 0.59 Kg (1.3 lbs) respectively. Thus nutritionalinterventions must take into account that the calves which are most sickare the ones who are least likely to obtain the nutrition they needthrough top dressing of feed.

Preconditioning of calves by vaccinating, bunk breaking them prior toweaning, and/or prophylactic administration of antibiotics often reducesthe morbidity and mortality during the initial 2-4 weeks followingtransporting to a new premises. The inability of the rancher to recoverthe costs associated with preconditioning has inhibited the adoption ofthese practices.

There are incidences where preconditioned calves succumb to BRD sicknessat rather high rates. This might result from neutralization of theadministered vaccines by residual maternal antibodies. A second reasonmay be that the administered vaccines do not correspond to theinitiating viral agents. Historically bovine rhinotracheitis (IBR)virus, bovine viral diarrhea (BVD) virus, parainfluenza virus type 3(PIV-3), and bovine respiratory syncytial virus (BRSV) have been seen asthe initiating agents of BRD. Recent evidence has established thatbovine coronavirus must also be added to the list of potentialinitiating viral infections.

A third reason may be that the bacterial component of BRD, such asPasteurella haemolytica or Pasteurella multocida, may be resistant tothe administered antibiotics. A final reason, which may encompasses allothers, is the inability of the calves' innate or acquired immunity toadapt under the increased stress of weaning, processing, and transport.

It is well established that good nutrition strengthens immunity incattle. The common addition of immune stimulant nutrients such as zincand vitamin E to the diet of stocker cattle provides essential buildingblocks for building a strong immune defense. Nevertheless the publishedBRD nutritional intervention studies have not been consistently positiveindicating that an unidentified deficiency still existed in theformulations studied.

Since most of the common medical treatments for the numerous medicalproblems discussed above and on the preceding pages can involve seriousside effects, compositions containing natural products andnutraceuticals that would treat these diseases and syndromes with lesscontraindications and diminish the development of antibiotic resistanceare highly desirable, not only to relieve suffering in the animals butalso to improve the quality of meat and human health.

SUMMARY OF THE INVENTION

This invention provides formulations of transfer factor in combinationwith minerals, antioxidants, amino acids and other nutraceuticalspreferably administered orally to treat animals exhibiting diseasesymptoms but also to lower general morbidity.

Accordingly, one aspect of this invention provides a formulationcomprising transfer factor, zinc and at least one essential fatty acid.

A second aspect of the invention is to provide a formulation of transferfactor, zinc, at least one essential fatty acid, vitamin C and yeast.

A third aspect of the invention is to provide a formulation of transferfactor, zinc, at least one essential fatty acid, vitamin C, yeast, ionicsalts or chelates of the elements calcium, phosphorous, selenium, iron,magnesium, manganese, copper, iodine, cobalt and molybdenum.

A fourth aspect of the invention is to provide a formulation of lacticacid generating bacteria, yeast, montmorillonite, vitamins A, B₂, B₆,B₁₂, E and K, biotin, folic acid, niacin, vitamin D₃, pantothenic acid,thiamine, lysine, methionine, arginine and methyl sulfonyl methane.

A fifth aspect of the invention is to provide a formulation comprisingtransfer factor, zinc, at least one essential fatty acid, vitamin C,yeast and ionic salts or chelates of the elements calcium, phosphorous,selenium, iron, magnesium, manganese, copper, iodine, cobalt andmolybdenium.

Another aspect of the invention is to provide a formulation of transferfactor, zinc, at least one essential fatty acid, vitamin C, ionic saltsor chelates of the elements calcium, phosphorous, selenium, iron,magnesium, manganese, copper, iodine, cobalt and molybdenum, lactic acidgenerating bacteria, yeast, montmorillonite, vitamins A, B₂, B₆, B₁₂, Eand K.

A further aspect of the invention is to provide a formulation oftransfer factor and lactic acid generating bacteria.

Yet another aspect of the invention is to provide a formulation oftransfer factor, zinc at least one essential fatty acid, vitamin C,ionic salts or chelates of the elements calcium, phosphorous, selenium,iron, magnesium, manganese, copper, iodine, cobalt and molybdenum,lactic acid generating bacteria, yeast, montmorillonite, vitamins A, B₂,B₆, B12, E and K, biotin, folic acid, niacin, vitamin D₃, pantothenicacid and thiamine.

Still another aspect of the invention is to provide a formulationcomprising transfer factor, zinc, at least one essential fatty acid,vitamin C, ionic salts or chelates of the elements calcium, phosphorous,selenium, iron, magnesium, manganese, copper, iodine, cobalt andmolybdenum, lactic acid generating bacteria, yeast, montmorillonite andvitamins A, B₂, B₆, B₁₂, E and K, and biotin, folic acid, niacin,vitamin D₃, pantothenic acid, thiamine, lysine, methionine, arginine,and methyl sulfonyl methane.

In yet another aspect, the invention provides the method of treatingCushing syndrome, Cushings disease, adenomas and other benign tumors,onchocerciasis or equine protozoal myelitis in an animal comprisingadministering to the animal a formulation of transfer factor, zinc andat least one essential fatty acid in an amount and at a frequency andfor a duration effective to decrease or eliminate the tumors or thesymptoms of those diseases.

A further aspect of the invention is to treat Cushing syndrome, Cushingsdisease, adenomas, onchocerciasis, hypothyroidism or equine protozoalmyelitis by administering to the animal a formulation of transferfactor, zinc and at least one essential fatty acid in combination withnutraceuticals selected from the group consisting of vitamin C, ionicsalts or chelates of the elements calcium, phosphorous, selenium, iron,magnesium, manganese, copper, iodine, cobalt and molybdenum, lactic acidgenerating bacteria, yeast, montmorillonite, vitamins A, B₂, B₆, B₁₂, Eand K, and biotin, folic acid, niacin, vitamin D₃, pantothenic acid,lysine, methionine, arginine and methyl sulfonyl methane. The preferredformulation for treating these diseases includes all of thenutraceuticals.

Still a further aspect of the invention is a method of treatinginflamation and ulcers in an animal comprising administering to theanimal in an amount at a frequency and for a duration effective toreduce or eliminate the symptoms of the inflamation or ulcers aformulation comprising transfer factor and lactic acid generatingbacteria.

Yet another aspect of this invention is a method of treating inflamationand ulcers in an animal comprising administering to the animal aformulation of transfer factor and other nutraceuticals selected fromthe group consisting of zinc, methyl sulfonyl methane, lactic acidgenerating bacteria, yeast, at least one essential fatty acid, vitaminC, ionic salts or chelates of the elements calcium, phosphorous,selenium, iron, magnesium, manganese, copper, iodine, cobalt andmolybdenum, montmorillonite, vitamins A, B₂, B₆, B₁₂, E and K, andbiotin, folic acid, niacin, vitamin D₃, pantothenic acid, thiamine,lysine, methionine and arginine and mixtures thereof in an amount, at afrequency and for a duration effective to reduce or eliminate thesymptoms of the inflamation or ulcers.

Still yet another aspect of the invention provides for a formulationcomprising transfer factor and a lactic acid generating bacteria.

Yet another aspect of the invention is to provide a formulation,comprising a transfer factor, lactic acid generating bacteria and zinc.

Still a further aspect of the invention is to provide for a formulationcomprising transfer factor, lactic acid generating bacteria, andmontmorillonite.

Still another aspect of the invention is a formulation comprisingtransfer factor, lactic acid generating bacteria, zinc, montmorillonite,at least one essential fatty acid, ionic salt or chelates of theelements calcium, phosphorous, selenium, iron, magnesium, manganese,copper, iodine, cobalt and molybdenum, yeast, vitamins A, B₂, B₆, B₁₂,C, E and K, biotin, folic acid, niacin, vitamin D₃, pantothenic acid,thiamine, lysine, methionine, arginine and methyl sulfonyl methane.

Another aspect of this invention provides for a method of treating fleabite dermatitis in an animal or feline leukemia in a cat comprisingadministering to the animal or cat a formulation of transfer factor andlactic acid generating bacteria in an amount and at a frequency and fora duration effective to reduce or eliminate the symptoms of thedermatitis or leukemia.

Still a further aspect of the invention provides for a method oftreating flea bite dermatitis in an animal or feline leukemia in a catcomprising administering to the animal or cat the formulation comprisingtransfer factor, lactic acid generating bacteria, zinc, montmorillonite,at least one essential fatty acid, ionic salt or chelates of theelements calcium, phosphorous, selenium, iron, magnesium, manganese,copper, iodine, cobalt and molybdenum, yeast, vitamins A, B₂, B₆, B₁₂,C, E and K, biotin, folic acid, niacin, vitamin D₃, pantothenic acid,thiamine, lysine, methionine, arginine, and methyl sulfonyl methane inan amount and at a frequency and for a duration effective to reduce oreliminate symptoms of the dermatitis or leukemia.

A further aspect of the invention is to provide a method of treatingstrangles, chronic dust allergen cough or hypothyroidism in an animalcomprising administering to the animal a formulation of transfer factorand a lactic acid generating bacteria in an amount and at a frequencyand for a duration effective to reduce or eliminate the symptoms of thestrangles, chronic dust allergen cough or hypothyroidism.

Still another aspect of the invention is a method of treatinglymphopenia in an animal comprising administering to the animal aformulation of transfer factor and a lactic acid generating bacteria inan amount, at a frequency and for a duration effective to reduce oreliminate the symptoms of the lymphopenia.

Still a further aspect of the invention is a method of reducingmorbidity in young livestock animals comprising administering to theanimals a formulation of transfer factor and a lactic acid generatingbacteria in a amount, at a frequency and for a duration effective toachieve a reduction in morbidity as compared to controls.

Yet another aspect of the invention is to provide a formulationcomprising transfer factor, lactic acid generating bacteria, ionic saltsor chelates of the elements calcium, magnesium, sodium and potassium,citric acid, vitamins A, B₂, B₆, B₁₂, C and E, and yeast.

Still another aspect of this invention is a method of treatingstrangles, chronic dust allergen cough or hypothyroidism in an animalcomprising administering to the animal a formulation of transfer factorand lactic acid generating bacteria and other nutraceuticals selectedfrom the group consisting of ionic salts or chelates of the elementscalcium, magnesium, sodium and potassium, citric acid, vitamins A, B₁,B₂, B₆, B₁₂, C and E, and yeast. The preferred formulation comprisestransfer factor, lactic acid generating bacteria and all of these othernutraceuticals.

A further aspect of the invention is to provide a formulation oftransfer factor and super oxide dismutase.

Another aspect of the invention is to provide a formulation of transferfactor and at least one glucosamine salt.

Still a further aspect of the invention is to provide a formulation oftransfer factor, super oxide dismutase and at least one glucosaminesalt.

Yet a further aspect of the invention is to provide a formulation oftransfer factor, super oxide dismutase, at least one glucosamine saltand chondroitin.

Yet an additional aspect of the invention is to provide a formulation oftransfer factor, super oxide dismutase, at least one glucosamine salt,chondroitin and glycine.

Still an additional aspect of the invention is to provide a formulationof transfer factor, super oxide dismutase, at least one glucosaminesalt, chondroitin, glycine and methyl sulfonyl methane.

Another aspect of the invention is to provide a formulation of transferfactor, super oxide dismutase, at least one glucosamine salt,chondroitin, glycine, methyl sulfonyl methane and boswellic acids.

Another aspect of the invention is to provide a formulation of transferfactor, super oxide dismutase, at least one glucosamine salt,chondroitin, glycine, methyl sulfonyl methane, boswellic acids andoctocosonol.

Another aspect of the invention is to provide a formulation of transferfactor, super oxide dismutase, at least one glucosamine salt,chondroitin, glycine, methyl sulfonyl methane, boswellic acids,octocosonol and montmorillinite.

Still a further aspect of the invention is to treat or cureinflammation, arthritis or laminitis with a formulation of transferfactor and super oxide dismutase.

Yet a further aspect of the invention is to treat or cure inflammation,arthritis or laminitis with a formulation of transfer factor andglucosamine salts.

Another aspect of the invention is to treat or cure inflammation,arthritis or laminitis with a formulation of transfer factor, superoxide dismutase and glucosamine salts.

Another aspect of the invention is to treat or cure inflammation,arthritis or laminitis with a formulation of transfer factor,glucosamine salts, super oxide dismutase, glycine, methyl sulfonylmethane, octocosonol and montmorillinite.

Yet a further aspect of the invention is a method of treatinglymphopenia in an animal comprising administering to the animal aformulation of transfer factor and lactic acid generating bacteria andother nutraceuticals selected from the group consisting of ionic saltsor chelates of the elements calcium, magnesium, sodium, potassium andzinc, citric acid, vitamins A, B₁, B₂, B₆, B₁₂, C and E, and yeast. Thepreferred formulation comprises transfer factor, a lactic acidgenerating bacteria and all of these other nutraceuticals.

Still yet another aspect of the invention is a method of reducingmorbidity in young livestock animal comprising administering to theanimals a formulation of transfer factor and lactic acid generatingbacteria and nutraceuticals selected from the group consisting of ionicsalts or chelates of the elements calcium, magnesium, sodium andpotassium, citric acid, vitamins A, B₁, B₂, B₆, B₁₂, C and E, and yeast.The preferred formulation comprises transfer factor, a lactic acidgenerating bacteria and all of these other nutraceuticals.

Other aspects of the invention will become apparent to the skilledartisan by the following description of the invention.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with this detailed description, the following definitionsand abbreviations apply.

Nutraceuticals—Nutrients used to treat or prevent a disease or syndrome.

Pharmaceutically acceptable—meant that the substance in the dose andform given is not known to cause serious side effects and harm apartfrom an occasional allergic reaction. In general, as used herein, theterm pharmaceutically acceptable has the same meaning as the commonmeaning for that term. However, the substance need not bepharmaceutically acceptable for humans unless the recipient is human.Nevertheless, it must be relatively safe for the animal receiving thesubstance.

EPM—Equine protozoal myelitis.

Various forms of transfer factor may be used in accordance with thisinvention. They include excreted transfer factor released from transferfactor containing cells such as lymphocytes and leukocytes, andcollected from extracellular fluids such as colostrum, blood and milk.Another form includes preexcreted transfer factor found within the cellor on the cell surface. Also substantially pure transfer factor definedas ribonuclease resistant polyribonucleotides having a molecular weightof less than 10,000 daltons and a specific activity of at least 5000units per adsorbance unit at 214 nM may also be used but is notnecessary for the results achieved in the course of this invention. Theinvention may also use transfer factor specific for an antigen obtainedby collecting transfer factor from an animal that has been exposed tothat antigen. An example of such an antigen may be Streptococcus equi.The transfer factor used in the Examples of this invention and referredto in the following Tables and further referred to in the rest of thedetailed description is extracted from colostrum collected from ageneral pool of lactating cows. The transfer factor, as used in theExamples, Tables and the following description, is further defined asdefatted water soluble material from bovine colostrum that will passthrough a nominal 10,000 molecular weight filter. Though bovinecolostral derived transfer factor was used to develop the formulationsof this invention, it is well known to anyone skilled in the art thatother kinds and sources of transfer factor could be used.

Table 2, shows a breakdown of a formulation of transfer factornutraceuticals and carriers for treating Cushing syndrome, Cushingsdisease, adenomas, onchocerciasis, hypothyroidism or EPM. In Table 2 andall the other tables references to “lb” (pounds) means pounds of bodyweight.

Columns 2, 3 and 4 of Tables 2-6 show the approximate high, low andpreferred amounts, respectively, of the formulation components, inamounts per body weight, to be given to an animal in a single dosage.The formulations in Tables 3 and 4 are very similar to the formulationof Table 2 but they are specialized for dogs and cats respectively. Theformulation represented in Table 2 is designed primarily for livestock.The 5 ounces of the formula listed in column 5 is designed to be givento a 1000 pound animal but that will vary and could be given to a 500pound animal in some cases. The average horse is around 1000 pounds. The28.3 gm dosage in Table 3 is calculated for a dog weighing about 100-200pounds but that dosage may also be given to a 15 pound dog. The 2.2 gmformula in Table 4 is for a cat weighing around 15 pounds. However,since these formulas are comprised of nutraceuticals and transferfactor, one skilled in the art will recognize that the ranges are notcertain and as critical as the ranges for allopathic drugs.

Further, the formulations in Tables 2-4 are designed to treat mainlychronic diseases, the formulation in Table 5 is designed for mainlyacute diseases and the formulation in Table 6 is for both acute andchronic diseases. All the formulations may be given in megadoses toachieve an acute response.

Administration of a formulation of transfer factor, zinc and at leastone essential fatty acid will result in at least a partially effectivetreatment of Cushings syndrome, Cushings disease, adenomas and otherbenign tumors, onchocerciasis, hypothyroidism or EPM. The treatment ismore effective as other nutraceuticals listed in Table 2 are added. Thedosage is in milligrams per pound unless otherwise stated. The amountsof the components present in a 5 ounce formulation transfer factorcontaining the other preferred nutraceuticals is shown in column 5 ofTable 2.

Transfer factor at a dosage of about 0.75 mg/lb in combination withabout 0.49 mg/lb zinc and 20.57 mg/lb of canola oil, safflower oil orflax oil, sources of essential fatty acids (i.e., 3, 6, 9 omega fattyacids), given once daily to an animal suffering from Cushings syndrome,Cushings disease, adenomas or other benign tumors, onchocerciasis,hypothyroidism or equine protozoal myelytis will result in approximatelya 30% to 50% reduction in the size of the benign tumors and/or thesymptoms of these listed diseases. All of these components should ofcourse be pharmaceutically acceptable to the animal receiving them.

A combination of Vitamin C at about 2.16 mg/lb and 2.29 mg/lb of yeastin combination with the above listed transfer factor and other fattyacid nutraceuticals will results in approximately a 40% to 50% reductionin the size of benign tumors and/or symptoms of the above listeddiseases.

It is preferred in all formulations of the invention that the metalnutraceuticals are proteinated because these forms are easier for theanimal to digest and also because the proteinate forms are more stableto pH. The nutraceutical components in the formulations in Tables 2-6are the active components for treating the various described diseasesand syndromes. The fillers and carriers are included to make theformulations more palatable to the animal and also to help preserve themixture. These include silicon dioxide, maltodextrin, soy and peanutflour, peanut oil, dextrose, whey, spices and flavorings. Mixedtocopherols and choline chloride are nutraceuticals but the effectiveresults described herein can still be achieved by deleting these twocomponents from the formulations.

A daily dosage of 141 mg per pound of body weight of any of theformulations in column 5 of Tables 2, 3 or 4, for 14 days has beensuccessful in treating feline pneumonitis, feline leukemia, felineautoimmune dysfunction, feline flea bit dermatitis, felinehyperthyroidism, feline viral infection, feline ulcerations, felinebacterial infection, canine flea bite dermatitis, canine Cushingsdisease, malignant tumors, canine autoimmune dysfunctiiion, canine viraland bacterial infection. These treatments for the most part haveresulted in complete cures.

Administering a formulation comprising all of the nutraceuticals inTable 2 at the preferred dosage to an animal with benign tumors resultedin about a 60% reduction in the size of the benign tumors and about a90% reduction in the symptoms exhibited by the animal suffering theabove listed diseases and syndromes.

Administration of all of the nutraceuticals in Table 2 at the low dosagein column 3 of those tables results in about a 7% to 100% reduction inthe size of the tumors and/or a 30% to 100% reduction in the symptomsexhibited by the animal suffering from those diseases or syndromes.

The stress formulation in Table 5 is also used to treat numerous animaldiseases and syndromes and as stated previously, mainly their acutestages. This formulation is also water soluble so it can be given in theanimals drinking water. A mixture of about 0.75 mg/lb transfer factorand about 1.42 mg/lb lactobacillus acidophilus 109 colony forming units(CFU) given twice daily will result in at least a 30% reduction inclinical symptoms resulting from strangles, dust cough, hypothyroidismand lymphopenia. The same dosage given to young calves will also reducemorbidity by about 30%. The addition of ionic salts or chelates ofcalcium, magnesium sodium and potassium twice daily in amountsapproximating those in column 4 of Table 5 to the above amounts oftransfer factor and lactic acid generating bacterial results in a 40%reduction in clinical symptoms of the above mentioned diseases. Theaddition of about 0.482 mg/lb of citric acid to the above formulationresults in about a 45% reduction in the symptoms of the above mentioneddiseases. Further addition of Vitamins A, B₂, B₆, B₁₂, C and E, andthiamine results in a 50% reduction in the symptoms of these diseases.The stress formulations given once or twice a day in the dosagepresented in column 4 of Table 5 will cure or at least treat and reducethe symptoms of autoimmune dust cough, diarrhea from viral etiology,abscessation, in strangles, snotty nose in strangles, acute viremia inswine, scratches in the horse, hypersensitivity from scratches andonchoceriasis, PURRS, BRD, calf dysentery, coliform infections,Rhodococcus infections, Clostidium infections, circo virus in birds, andpnemonitis in cats. A combination of transfer factor and lactic acidproducing bacteria or this combination further combined with yeast asshown in Table 5 will also treat these diseases but to a lesser extent.

The stress formulation as shown in Table 5 given once or twice dailywill also increase the weight gain and feed efficiency of livestock. Theweight gain will increase by at least 8%. A combination of transferfactor and lactic acid producing bacteria or this combination furthercombined with yeast as shown in Table 5 will also increase weight gainbut to a lesser extent.

Table 6 shows a breakdown of a performance formulation of transferfactor and nutraceuticals for treating and curing numerous diseases suchas arthritis, laminitis, inflammation and malignant tumors. Thesediseases may also be treated with a combination of transfer factor andsuper oxide dismutase; transfer factor and glucosamine salts; transferfactor, glucosamine salts and super oxide dismutase; transfer factor,glucosamine salts, super oxide dismutase and glycine; transfer factor,glucosamine salts, super oxide dismutase, glycine and methyl sulfonylmethane; transfer factor, glucosamine salts, super oxide dismutase,glycine, methyl sulfonyl methane and octocosonol or transfer factor,glucosamine salts, super oxide dismutase, glycine, methyl sulfonylmethane, octocosonol and montmorillinite.

TABLE 2 Premix Formulation (Amounts in mg/lb of body weight unlessotherwise stated) Dosage: mg/5 oz. Component High Low Preferred offormula 1-Arginine 0.5 0.005 0.05 50.00 *Lacto yeast (4.9% of blend)69.51 0.6951 6.91 6951.88 Montmorillinite   1 gm/lb 0.24118 2.41182411.88 Canola oil (14.5% mix) 1.5 gm/lb 2.05 20.571 20571.88 Saffloweroil (14.5% mix) 1.5 gm/lb 2.05 20.57 20571.88 Flax seed oil (55% Alpha1.5 gm/lb 2.05 20.571 1418.75 Linolenic Acid) (1.0% mix) Phosphorous(Monosodium 15.750 gm 0.0525 5.08 5080.00 phosphate) 12% Calciumcarbonate 8.5%  13.68 gm 0.0485 4.88 4880.00 (38% calcium) Methylsulfonyl methane 20 0.02 2 2000.00 Transfer factor 50.00 0.05 0.75750.00 Vitamin C (ascorbic acid) 21.62 0.2162 2.162 2162.50 d-Biotin(Vitamin H 2%) 9.73 0.000973 0.00973 10.00 Vitamin D₃ 29.16 IU 0.7298 IU 7.298 IU  7298.38 IU Vitamin B₁₂ 0.092 0.000092 0.00092 0.92 Folic Acid1 0.001006 0.01006 10.06 Niacinimide 12 0.012157 0.12157 121.57Pantothenic acid (d-Calcium 0.324 0.0108 0.108 108.00 Pantothenate)91.6% Vitamin B₆ (Pyridine Hcl) 82.3%) 1.158 0.001158 0.01158 11.58Vitamin A (Retinol Palmitate)   600 IU  4.02 IU 40.212 IU 40232.50 IU650 M IU/g feed grade Vitamin B₂ 0.0554 0.002776 0.02776 27.76 Thiamine(Mononitrate) 83% 3.09 0.00308 0.0308 30.80 Vitamin E  72.9 IU 0.0729 IU 0.729 IU  729.42 IU Vitamin K 1 0.0007 0.007 7.00 Cobalt (Proteinate)5% 0.00043 0.000043 0.00043 0.43 Copper (Proteinate) 10% 0.56 0.01120.112 112.00 Iodine (Potassiumiodide) 98% 0.005 0.000053 0.00053 0.53Iron (Proteinate) 15% 3.31 0.0331 0.331 331.16 Magnesium (Oxide) 58% 100.04 0.4 400.00 Manganese (Proeinate) 15% 1.65 0.04 0.4 332.10Molybdenum (Sodium Molybdate 0.05 0.001 0.01 10.00 Dihydrate) 39%Selenium (Sodium Selenite) 44.8% 0.00162 0.000081 0.00081 1.00 Zinc(Proteinate) 15% 50 0.04987 0.4987 498.72 1-Lysine (Mono HCl) 8.410.0841 0.841 841.57 d,1-Methionine 11.03 0.1103 1.103 1103.86 MixedTocopherols 300.00 Choline Chloride 2434.00 Sipernat 50 (Silicondioxide) 12768.75 Lodex-5 (maltodextrin) 7519.38 Soy flour (17.5% mix)24828.13 Sweet whey 996.00 BF70 spice 146.00 Dextrose powder 750.00*Lactic acid generating bacteria is two-thirds of component and yeast isone-third; lactic acid generating bacteria is 500,000,000 CFU/gm, yeast(e.g., “Saccharamyces”) 250,000,000 CFU/gm

TABLE 3 Canine Premix Formulation (Amounts in mg/lb of body weightunless otherwise stated) Dosage: mg/28.37 gm Component High LowPreferred of formula 1-Arginine 0.5 0.005 0.05 10.00 *Lacto yeast (4.9%of blend) 69.51 0.6951 6.91 1390.38 Montmorillinite   1 gm/lb 0.241182.4118 482.20 Canola oil (14.5% mix) 1.5 gm/lb 2.05 20.571 3887.00Safflower oil (14.5% mix) 1.5 gm/lb 2.05 20.57 3887.00 Flax seed oil(55% Alpha 1.5 gm/lb 2.05 20.571 240.00 Linolenic Acid) (1.0% mix)Phosphorous (Monosodium 15.750 gm 0.0525 5.08 1010.00 phosphate) 12%Calcium carbonate 8.5%  13.68 gm 0.0485 4.88 977.00 (38% calcium) Methylsulfonyl methane 20 0.02 2 400.00 Transfer factor 50.00 0.05 2.50 500.00Vitamin C (ascorbic acid) 21.62 0.2162 2.162 432.50 d-Biotin (Vitamin H2%) 9.73 0.000973 0.00973 2.00 Vitamin D₃ 29.16 IU 0.7298 IU  7.298 IU1459.68 IU Vitamin B₁₂ 0.092 0.000092 0.00092 0.18 Folic Acid 1 0.0010060.01006 2.16 Niacinimide 12 0.012157 0.12157 24.31 Pantothenic acid(d-Calcium 0.324 0.0108 0.108 21.60 Pantothenate) 91.6% Vitamin B₆(Pyridine Hcl) 1.158 0.001158 0.01158 2.32 82.3%) Vitamin A (RetinolPalmitate)   600 IU  4.02 IU 40.212 IU 8046.50 IU 650 M IU/g feed gradeVitamin B₂ 0.0554 0.002776 0.02776 5.55 Thiamine (Mononitrate) 83% 3.090.00308 0.0308 0.16 Vitamin E 72.9 IU 0.0729 IU  0.729 IU  145.88 IUVitamin K 1 0.0007 0.007 1.40 Cobalt (Proteinate) 5% 0.00043 0.0000430.00043 0.086 Copper (Proteinate) 10% 0.56 0.0112 0.112 22.40 Iodine(Potassiumiodide) 98% 0.005 0.000053 0.00053 0.106 Iron (Proteinate) 15%3.31 0.0331 0.331 66.23 Magnesium (Oxide) 58% 10 0.04 0.4 80.00Manganese (Proeinate) 15% 1.65 0.04 0.4 66.42 Molybdenum (SodiumMolybdate 0.05 0.001 0.01 2.00 Dihydrate) 39% Selenium (Sodium Selenite)0.00162 0.000081 0.00081 0.20 44.8% Zinc (Proteinate) 15% 50 0.049870.4987 99.74 1-Lysine (Mono HCl) 8.41 0.0841 0.841 176.91 d,1-Methionine11.03 0.1103 1.103 220.77 Mixed Tocopherols 60.00 Choline Chloride486.80 Sipernat 50 (Silicon dioxide) 2553.35 Lodex-5 (maltodextrin)1508.87 Peanut oil 496.56 Soy flour (17.5% mix) 4965.02 Peanut flour4965.02 Sweet whey 400.00 BF70 spice 29.20 Dextrose powder 500.00*Lactic acid generating bacteria is two-thirds of component and yeast isone-third; lactic acid generating bacteria is 500,000,000 CFU/gm, yeast(e.g., “Saccharamyces”) 250,000,000 CFU/gm

TABLE 4 Feline Premix Formulation (Amounts in mg/lb of body weightunless otherwise stated) Dosage: mg/2.2 gm Component High Low Preferredof formula 1-Arginine 0.5 0.005 0.05 0.78 *Lacto yeast (4.9% of blend)69.51 0.6951 6.91 108.42 Montmorillinite   gm/lb 0.24118 2.4118 37.00Canola oil (14.5% mix) 1.5 gm/lb 2.05 20.571 323.25 Safflower oil (14.5%mix) 1.5 gm/lb 2.05 20.57 323.25 Flax seed oil (55% Alpha 1.5 gm/lb 2.0520.571 22.13 Linolenic Acid) (1.0% mix) Phosphorous (Monosodium 15.750gm 0.0525 5.08 78.70 Calcium carbonate 8.5%  13.68 gm 0.0485 4.88 75.69(38% calcium) Methyl sulfonyl methane 20 0.02 2 31.20 Transfer factor50.00 0.05 16.00 250.00 Vitamin C (ascorbic acid) 21.62 0.2162 2.16233.73 d-Biotin (Vitamin H 2%) 9.73 0.000973 0.00973 0.156 Vitamin D₃29.16 IU 0.7298 IU  7.298 IU 113.90 IU Vitamin B₁₂ 0.092 0.0000920.00092 0.014 Folic Acid 1 0.001006 0.01006 0.168 Niacinimide 120.012157 0.12157 1.90 Pantothenic acid (d-Calcium 0.324 0.0108 0.1081.68 Pantothenate) 91.6% Vitamin B₆ (Pyridine Hcl) 1.158 0.0011580.01158 0.18 82.3%) Vitamin A (Retinol Palmitate)   600 IU  4.02 IU40.212 IU 627.60 IU 650 M IU/g feed grade Vitamin B₂ 0.0554 0.0027760.02776 0.43 Thiamine (Mononitrate) 83% 3.09 0.00308 0.0308 0.48 VitaminE  72.9 IU 0.0729 IU  0.729 IU  11.38 IU Vitamin K 1 0.0007 0.007 0.11Cobalt (Proteinate) 5% 0.00043 0.000043 0.00043 0.006 Copper(Proteinate) 10% 0.56 0.0112 0.112 1.75 Iodine (Potassiumiodide) 98%0.005 0.000053 0.00053 0.008 Iron (Proteinate) 15% 3.31 0.0331 0.3315.17 Magnesium (Oxide) 58% 10 0.04 0.4 6.24 Manganese (Proeinate) 15%1.65 0.04 0.4 5.18 Molybdenum (Sodium Molybdate 0.05 0.001 0.01 0.156Dihydrate) 39% Selenium (Sodium Selenite) 0.00162 0.000081 0.00081 0.15644.8% Zinc (Proteinate) 15% 50 0.04987 0.4987 7.78 1-Lysine (Mono HCl)8.41 0.0841 0.841 13.80 d,1-Methionine 11.03 0.1103 1.103 17.22 MixedTocopherols 4.68 Choline Chloride 38.0 Sipernat 50 (Silicon dioxide)199.06 Lodex-5 (maltodextrin) 117.30 Sweet whey 155.37 BF70 spice 2.28Dextrose powder 250.00 Glucosamine HCl 100.00Pernaconniculus-Chondroitin 200.00 *Lactic acid generating bacteria istwo-thirds of component and yeast is one-third; lactic acid generatingbacteria is 500,000,000 CFU/gm, yeast (e.g., “Saccharamyces”)250,000,O0O CFU/gm

TABLE 5 Stress Formula (Amounts in mg/lb of body weight unless otherwisestated) Dosage: mg/ounce Component High Low Preferred of formula CalciumPantothenate 1.80 0.09 0.028 28.00 Vitamin C (ascorbic acid) 20.00 0.0560.017 17.00 Vitamin B₁₂ 13.00 0.13 0.198 198.59 Vitamin A 600.00 IU 0.10 IU 0.014 14.00 Vitamin B₂ 1.20 0.065 0.018 18.00 Thiamine 16.000.0308 0.017 17.00 Vitamin E  72.9 IU 0.729 IU 0.012 12.48 MagnesiumSulfate 10.00 0.113 0.113 113.00 *Lactobacillus acidophilus 10.00 0.4671.418 1418.00 Sodium Chloride 166.00 0.236 2.368 2368.00 Dipotassiumphosphate 116.00 5.85 1.773 1773.00 Citric acid 31.00 1.59 0.482 482.00Yeast (hydrolyzed) 180.00 0.1957 0.283 283.00 Glycine 0.142 0.0142 0.142141.80 Potassium chloride 18.00 0.93 0.283 283.00 Vitamin D₃ 29.00 0.7290.002 1.56 Dextrose 40.00 2.00 21.38 21375.00 Artificial flavor 0.0280.0028 28.548 28.30 Transfer Factor 50.00 0.05 0.75 750.00 Sipernat(silicon dioxide) 0.05 56.70 *10⁹ colony forming units (CFU)/gm

TABLE 6 Performance Formula (Amounts in mg/lb of body weight unlessotherwise stated) Dosage: mg/oz. Component High* Low* Average* offormula Super oxide dismutase 60.0 0.6 6.0 6000.0 Glucosamine salts 65.00.65 6.5 6500.0 Transfer factor¹ (horses, 15.0 0.15 1.5 1500.0 cows)Transfer factor¹ (goats) 10.0 0.10 1.0 3000.0 Transfer factor¹ (dogs,cats) 50.0 0.5 5.0 14000.0 Pernaconniculus-Chondro- 16.5 0.165 1.651650.0 itin (mucopolysaccharides) Boswellic acids 30 0.3 3.0 3000.0Di-methyl glycine 27.0 0.27 2.7 2700.0 Methyl sulfonyl methane 27.0 0.272.7 2700.0 Octocosonol 2.0 0.004 0.04 400.0 Montmorillinite 30.0 0.3 3.03000.0 *These amounts are calculated for livestock animals weighingabout 450 to 1,000 pounds, goats weighing about 150 pounds, and dogs andcats weighing from about 8 to about 15 pounds. ¹The amount of transferfactor may vary for different species but the amounts for the othercomponents remain the same for each species.

The following examples serve to more fully describe the manner of usingthe above-described invention, as well as to set forth the best modescontemplated for carrying out various aspects of the invention. It isunderstood that these examples in no way serve to limit the true scopeof this invention, but rather are presented for illustrative purposes.All patents, patent applications, publications, and references citedherein are expressly incorporated by reference in their entirety.

EXAMPLE 1

A seven year old warm blooded Pajarro horse was urinating frequently andshowing other clinical signs of pre Cushings syndrome. Morning andevening thyroid readings of 22.33 ng and 19.8 ng and insulin readings of31.0 UIU and 43.2 UIU respectively confirmed this diagnosis. The horsewas place on a daily dose of 5 ounces of the premix formulation as shownin column 5, Table 2. After seven days on the formulation the frequencyof urination had greatly decreased and the horse's temperament hadsignificantly improved. Blood studies taken 32 days after the initiationof treatment, which showed morning and evening thyroid readings of 28.4ng and 42.7 ng and insulin readings of 40.3.0 UIU and 33.62 UIU,respectively, exhibited an improved thyroid level and cortisol rhythm.

EXAMPLE 2

Two horses, one 7 years old and the other a yearling, exhibited signs ofchronic dust cough, a condition that has an allergic component withincreased eosinophilia. The 5 year old thoroughbred had been treatedwith tribrissin and an antihistamine. His intake eosinophil count was 8and the monocyte count was 7. After being placed on 1 ounce of thestress formulation as shown in column 5, Table 5, twice daily for 14days, the horse appeared to be in complete remission. He was then placedon a treatment of 5 ounces daily of the premix formulation as shown incolumn 5, Table 2. At the end of 22 days, the cough was completelyeliminated and the eosinophil count was down to 3 and the monocyte countwas down to 6. The yearling who had been on expensive antibiotics andcough suppressants showed no clinical symptoms of the chronic coughafter receiving a daily dose of 5 ounces of the premix formulation asshown in column 5, Table 2, for 10 days.

EXAMPLE 3

Two horses were received that had been positively diagnosed withCushings disease and had previously been treated with Pergolyde andCyprohexadine. One of the horses had initial morning and evening thyroidreadings of 5.3 ng and 7.4 ng and insulin readings of 142.8UIU and110.2UIU, respectively. Both horses showed dramatic improvement after 10days on a daily 5 ounce dosage of the premix formulation as shown incolumn 5, Table 2. Both horses continued with a positive response afterbeing maintained for 2 months on the same dosage. Morning and eveningblood results of thyroid readings of 7.0 ng and 16.1 ng and insulinreadings of 110.3UIU and 65.2UIU confirmed improvements in thyroidfunction and cortisol rhythm.

EXAMPLE 4

The stress formulation (Table 5) was used successfully to treat twothoroughbred racehorses with chronic dust cough. After 5 days ofreceiving two ounces per day of the stress formulation shown in column5, Table 5, both horses had dramatically improved with one horse nolonger showing any symptoms of the eosinophilic dust cough and the otherhorse showing approximately a 60% improvement over its previoussymptoms.

EXAMPLE 5

Three pigs with acute viral infection and temperatures of 105° wereplaced on one ounce daily of the stress formulation shown in column 5,Table 5. Within 24 hours, all three pigs ate normally and exhibitednormal temperatures.

EXAMPLE 6

Two foals, 10 and 12 days old, suffering from diarrhea had not respondedto previous treatments of antibiotics and electrolytes. Both foals wereplaced on one ounce of the stress formulation as shown in column 5,Table 5, twice daily. After two days on this treatment, both foals weresymptom free.

EXAMPLE 7

An 80 pound golden retreiver that has reoccurring squamous cellcarcinoma was given 28 grams of the canine formula as shown in column 5,Table 2, per day for 6 weeks. The 6-week administration of thisformulation per day showed a 40% reduction in the tumor.

EXAMPLE 8

Five cats were suffering from upper respiratory infections. They weretreated with a dosage of the stress formulation in milligrams per poundas shown in column 4, Table 5. All cats responded with remission ofsymptoms in three days after initiation of this treatment.

EXAMPLE 9

A 16 year old gelding, Dutch warm blood was exhibiting no energy,irritability, awkward movement, a chronic girth itch and was unable tocarry his head correctly. A blood test showed a low lymphocyte count of624/uL, with 1500 to 7700/uL being normal, and also showed a marginallylow T4 thyroid count of 1.0 ug/dL. He had been receiving long termtreatments of Trimethoprim Sulfur, vitamins and some nutritionalchanges. This treatment was stopped and he was administered orally 1 ozof the stress formulation twice daily as shown in column 5 of Table 5for a few days and showed some improvement. He was then placed on adaily oral dose of 5 oz of the premix formulation as shown in column 5of Table 2. After 5 days of treatment the horse was significantlyimproved, eating better and holding his head erect. A blood test takenseven days after the premix formulation treatment began showed that thelymphocyte count had increased to 940/uL. Approximately 35 days aftertreatment with the premix formulation, another blood test showed alymphocyte count improvement to 1404/uL and a thyroid increase to 1.5ug/dL. A normal thyroid range is 0.9 ug/dL to 2.8 ug/dL. His clinicalappearance was excellent, locomotion had improved, cervical balance wasbetter and the girth itch appeared 80 percent improved. He has remainedwell and is being used as a normal performance horse in three-dayeventing.

EXAMPLE 10

A seven year old mustang gelding with a three year duration ofonchocerciasis exhibiting stomach ulceration and severe pruritus of tailand main, had been treated with conventional cortisone and antibioticswith little success. The horse was placed on a daily oral treatment of 5oz. of the premix formulation as shown in column 5 of Table 3. After twomonths a blood test showed that the white blood cell counts hadstabilized. After six months the thyroid level was normal, the clinicalsymptoms had gone and the horse was in complete remission.

EXAMPLE 11

Approximately 60 young foals were suffering from severe cases ofstrangles also known as Strep Equi, a secondary infection of Rhodococcusequi and upper respiratory infections. The problem was being complicatedby heat causing dehydration and also by dust. Most of the foals werealso suffering from dust pneumonia. The foals had not responded toprevious conventional therapy of antibiotics, of gentomycin sulfate,penicillin, amikacin. Twenty-one of the foals were first treated withone ounce of the stress formulation shown in column 5, Table 5, twice aday for two days and then were treated with one ounce once a day forthree more days. Three foals showed significant recovery after fivedays. These three foals were treated with one ounce of the stressformulation described above twice a day and no antibiotics. Two of thefoals that had just contracted the disease responded immediately in 48hours showing very little coughing, clear nostrils and increasedappetite. The other foal had to be placed on antibiotics in addition tothe stress formulation and responded in five days with supportiveantibiotics. The remaining 18 diseased foals with strangles and upperrespiratory ailments received one ounce twice daily of the stressformulation in column 5, Table 5 for two days and then received oneounce daily of the same stress formulation for the next 8 days. Bloodtests were initially taken on these foals and again ten days aftertreatment began.

About 14 of these remaining foals showed a marked improvement after 10days with no antibiotics. The initial blood results show elevatedneutrophil and monocyte counts on the majority of the foals with highband cell counts. Foals with early signs of the strep equi infectionshowed depressed lymphocyte counts. After ten days of treatment bloodresults showed normalization of the differential of neutrophils,lymphocytes, and monocytes. The most significant finding was totalreduction of band cells in all but one foal. Platelet cells wereincreased in practically all foals.

Reduction of band cells is indicative of a powerful immune response. Theplatelet cell increase may be from stimulation of stem cells. Hydrationimproved from the electrolyte and probiotic combination with transferfactor. Also, as an adjunct to antibiotic therapy, the stress formulaappeared very beneficial and in early onset of disease the stressformula appeared to boost the immune response to the extent thatantibiotic therapy may not be necessary.

The problem with treating strangles with antibiotics is that for somereason antibiotics allow the “Strep equi” organism to lie dormantcausing a disease of bastard strangles later in life in that lymph nodescontaining the bacteria can show up at any age and create a chronicillness or acute death.

EXAMPLE 12

This case involved dairy drop calves. These calves usually receive verylittle colostrum if any and, upon arrival at the farm, frequently breakwith shipping fever symptoms, the term used for generalized viralinfections, upon arrival at the farm. These symptoms usually last tendays with conventional antibiotic therapy and result in a high mortalityrate. However, the disease also often leaves permanent scarring of thelungs and gastrointestinal tract which leaves poor producing dairy cows.Ten of the calves received one ounce daily of the stress formulation asset forth in column 5, Table 5, for four days and then one half ounce ofthat formulation for the next three days. The ten controls received nostress formulation. After 7 days, one of the stress formulation treatedcalves contracted shipping fever and had to be treated with antibiotics.Out of the 10 controls, 7 calves had to be treated with antibiotics. Theoverall test showed a 60 to 80 percent reduction in morbidity.

EXAMPLE 13

A 10 year old 70 pound golden retriever suffering with a squamouspapilloma of the eyelid of a clinical size of about 1cm in length,received surgery to remove the tumor. Within two months the tumor hadreoccurred and had grown rapid rapidly again to 1 cm. The retriever wasplaced on a daily dosage of 28 grams of the canine formula as shown incolumn 5, Table 3. After 60 days on this dosage of the canine formula,not only had the tumor stopped growing but the size of the tumor wasreduced by 30%.

EXAMPLE 14

A 1000 pound horse was suffering from scratches. Scratches is abacterial, fungal infection of the rear legs consisting ofstaphilococcus and Trichophyton mentagreophytes. After 7 days ofreceiving 1 ounce twice daily of the stress formulation as shown incolumn 5, Table 5, the infection on the rear legs had improved at least50% and the swelling and sores that had occurred were greatly reduced.

EXAMPLE 15

A nine year old thoroughbred cross, gelding, performance horse exhibitedclinical signs of Cushing's syndrome, including heavy breathing, ulcersaround the coronet band and hypothyroidism. He had previously beentreated with Azium, Ventipulium, prednisone and broncodilators butshowed no improvement. A daily treatment of approximately 5 oz. of thepremix formulation as set forth in column 5 of Table 2 showed someimprovement. After the addition of 750 mg of transfer factor to theabove Premix dosage, all given daily, the horse showed immediate andsignificant improvement in it's performance. The horse continued toimprove and after being kept on the same transfer factor and premixformulation, the horse recovered completely. When the horse was takenoff the transfer factor and premix, he relapsed but recovered afterbeing placed again on the same transfer factor and premix formulationagain.

EXAMPLE 16

A 1,000-pound gelding suffering from onchoceriasis as exhibited by skinthickness and other symptoms is administered 750 mg of transfer factor,500 mg of total zinc and 2 gm of flax seed oil. The onchoceriasissymptoms are reduced as exhibited by a 60% reduction in skin thickness.

EXAMPLE 17

A 1000 pound horse with a temperature of 103° F. is given 750 mg oftransfer factor, 500 mg of total zinc, 2 gm of Flax seed oil, 7 gm ofhydrolyzed yeast and 1.5 gm of Vitamin C. The horse shows a reducedtemperature of approximately 100.5° F. within 48 hours.

EXAMPLE 18

A 1000 pound gelding exhibiting a low lymphocyte count is given a dailydosage of 750 mg of transfer factor, 500 mg of total zinc, 2 gm of Flaxseed oil, 7 gm of hydrolyzed yeast, 1.5 gm of Vitamin C, 2 gm of methylsulfonyl methane, 15 mg of arginine and 1103.86 mg of methionine. Afterbeing given this dosage for 30 days, the lymphocyte count of the geldingis increased 30%.

EXAMPLE 19

A colt weighing 1000 pounds with a bacterial infection with a minor cuton the leg and a temperature of 105° is given 750 mg of transfer factorand 2.35 gm of lactobacillus acidophilus. With 48 hours afteradministration of this composition, the temperature is reduced to 101°F. and the swelling is reduced approximately 50%.

EXAMPLE 20

A 3-year old 1000 pound colt having a respiratory infection that isviral in origin with a temperature of 104° responds to 750 mg oftransfer factor, 2.3 gm of lactobacillus acidophilus, 500 mg of zinc and3 gm of yeast given daily by showing a reduction in temperature toapproximately 101.50° F. and improved breathing within 72 hoursfollowing the initiation of this treatment.

EXAMPLE 21

A 1000 pound horse with hoof separation from white line disease andmicro absecessation responds to a daily dosage of 750 mg of transferfactor, 2.3 gm of lactobacillus acidophilus, 500 mg of total zinc, 3 gmof yeast and 24.12 gm of montmorillinite. After 90 days of treatment thehorse shows improved hoof growth of approximately 1 cm and approximatelya 60% reduction of white line disease or absecessation.

EXAMPLE 22

A 1000 pound gelding with Cushings disease is fed 5 ounces daily of thepremix formulation shown in column 5, Table 2, except that the horsereceives 3 gm of Flax seed oil and no canola oil or safflower oil. With30 days of continuous treatment at this dosage, the clinical symptoms offrequent urination, low blood sugar and low alertness are improvedapproximately 30%. With 90 days at this treatment, the Cushings symptomsare 50% reduced.

EXAMPLE 23

A 15-pound cat with flea bite dermatitis is treated with 250 mg oftransfer factor, 108 gm of lactobacillus acidophilus for 10 days andshowed a 40% improvement in arithmic ulcerations of the skin caused bythe flea bites.

EXAMPLE 24

A 15 pound cat with reddened skin under the stomach and partial hairloss from flea bite dermatitis and possibility autoimmune or atopicdermatitis is treated daily with 250 mg of transfer factor, 37 mg oflactic acid bacteria, 72 mg of hydrolyzed yeast, 7.78 mg of zinc and37.6 mg of montmorillinite for 10 days. The clinical symptoms ofreddened skin and hair loss at the end of this time are reducedapproximately 50%.

EXAMPLE 25

A 15 pound cat tests positive to feline leukemia virus. With 60 daystreatment of a daily dose of 250 mg of transfer factor, 37 mg oflactobacillus acidophilus, 7.78 mg of zinc and 72 mg of hydrolyzedyeast, the cat is no longer exhibiting clinical symptoms of felineleukemia virus and the laboratory tests are negative.

EXAMPLE 26

A 15 pound cat with flea bite dermatitis is treated daily with 250 mg oftransfer factor, 37 mg of lactobacillus acidophilus, 72 mg of hydrolyzedyeast and 37.6 mg of montmorillinite. Within 7 days of daily treatment,the ulcerations occurring from the flea bite dermatitis are at least 40%reduced.

EXAMPLE 27

One day old drop dairy calves weighing 100 pounds each with shippingfever exhibiting clinical symptoms of poor appetite, diarrhea and anelevated fever are administered a daily dosage in their food of 375 mgof transfer factor, 709 mg of lactobacillus acidophilus, 14 mg ofcalcium pantothenate, 56.5 mg of a chelated magnesium, 1158 mg of asodium salt, 141 mg of a potassium salt and 881 mg of a phosphate.Within 4 days of receiving this treatment, the morbidity rate in thecalves is reduced 50% as compared to controls.

EXAMPLE 28

Ten pigs each weighing 10 pounds and exhibiting elevated temperaturesand slightly loose stool are administered 250 mg of transfer factor, 467mg of lactobacillus acidophilus, 9.24 mg of calcium pantothenate, 37 mgof magnesium, 781 mg of a sodium salt, 93 mg of a potassium salt and 585mg of phosphorus in the form of dipotassium phosphate along with 15 mgof citric acid daily. These pigs exhibit a 50% reduction in morbiditywithin 5 days of administration of this formulation in comparison tocontrols that do not receive the formulation.

EXAMPLE 29

Ten show chickens weighing 10 pounds each show signs of elevatedtemperature, distress from shipping fever complex that is viral inorigin, poor appetite and lethargy. A daily dosage of 250 mg of transferfactor, 467 mg of lactobacillus acidophilus, 924 mg of a chelatedcalcium pantothenate, 37 mg of a magnesium sulfate, 781 mg of a sodiumsalt, 93 mg of a potassium salt, 585 mg of dipotassium phosphate, 159 mgof citric acid, 4.62 mg Vitamin A, 5.4 mg Vitamin B₂, 65.3 mg VitaminB₁₂, 5.8 mg Vitamin C and 4.1 mg Vitamin E daily in their drinking waterreduces morbidity 50% within 72 hours as compared to a control groupthat does not receive this treatment.

EXAMPLE 30

Five horses weighing approximately 500 pounds each with Strangles asexhibited by snotty noses, elevated temperatures and swollen lymph nodesare administered 750 mg of transfer factor, 1.42 gm of lactobacillusacidophilus, 28 mg of calcium pantothenate, 113 mg of magnesium sulfate,2368 mg of sodium chloride, 283 mg of potassium chloride, 1773 mg ofdipotassium phosphate, 482 mg of citric acid along with 14 mg Vitamin A,18 mg Vitamin B₂, 17 mg Thiamine, 1,56 mg Vitamin D₃, 17 mg Vitamin Cand 12.48 mg Vitamin E, twice daily. The morbidity rate for these horsesis reduced 50% as shown by a 50% reduction in symptoms when compared toa control group not receiving the above formulation. Chronicabscessation is eliminated approximately 40% again when compared to acontrol group not receiving the above formulation.

EXAMPLE 31

A 1000 pound horse with a flat sarcoid in the ear tip is given 5 ouncesof the premix formulation as shown in column 5 of Table 2 daily for 60says. At the end of the 60-day treatment, the sarcoid is reduced 30% insize.

EXAMPLE 32

A serious outbreak of mycoplasma occurs in 20 goats exhibiting symptomsof ocular and nasal discharge. The milking goats are also sufferingmastitis as a result of the disease. The goats are given 1 ounce dailyof the stress pak formulation shown in column 5, Table 4, for 7 days. A40% improvement in the clinical symptoms of the mycoplasma is seen withadministration of this stress dosage.

EXAMPLE 33

A 1000 pound warmblooded horse having equine protozoal myelitis istreated daily for four weeks with 5 ounces of the premix formula asshown in column 5, Table 2, in addition to traditional medication suchas pyrimethamine and sulfadiazine. This treatment produces a 50%improvement in symptoms.

EXAMPLE 34

A 1000 pound Arabian horse having a one inch melanoma situated below thetail head and growing at ½ inch per 6 months is treated for 60 days with5 ounces daily of the premix formulation as shown in column 5, Table 2.This treatment stops the growth of the melanoma and reduces the size ofthe tumor about 20%.

EXAMPLE 35

Group I

Two hundred forty crossbred heifers are randomly divided into threegroups of 80 calves each. They are processed within 12 hours afterarrival, individually weighed and receive a combination modified-livevirus vaccine consisting of infectious bovine rhinotracheitis (IBR)virus, killed bovine viral diarrhea virus (BVD), modified-live bovinerespiratory syncytial virus (BRSV) and killed parainfluenza-3 (PI3)virus, a multivalent bacterin-toxoid against 7 clostridial species; adormectin dewormer (Ivomec); and a progesterone implant. Ten daysfollowing processing, the calves are given a booster with the samemodified-live vaccine they received initially. One set of 80 calvesaveraging 440.1 pounds receive a 1 ounce dose of the stress formula, asset forth in column 5, Table 5, dissolved in 1 ounce water viadosesyringe at the time of processing. Thereafter, they are given dosesof 1 ounce of stress formula daily mixed in the feed (total mixedration—TMR) for four days after processing. A second set of 80 calvesaveraging 440 pounds receive 1.5 ml/cwt of tilmicosin (Micotil) at thetime of initial processing. The third set of 80 averaging 449.9 poundsserves as controls. The sets are observed for 26 days after processingat which time each of the calves is again weighed and feed efficiencycalculated collectively for each group.

Group II

Two hundred crossbred stocker heifers are randomly divided into fourgroups of 50 calves each. They are processed in the same manner as thestocks in Group I. One set of 50 calves averaging 441 pounds receives 1ounce of the stress formula as set forth in column 5, Table 4, per dayin their TMR for five days. A second set of 50 calves averaging 433pounds receive ½ ounce of the same stress formula in their TMR for fivedays. A third set of 50 calves averaging 447 pounds receive ametaphylactic 1.5 ml of tilmicosin per cwt at the time of initialprocessing. The fourth set of 50 calves averaging 432 pounds serve ascontrols. Each heifer in all four sets receives the modified live viruscombination of IBR, PI3, BVD and BSV vaccine booster ten days followinginitial processing. The groups are observed for 30 days after processingat which time each of the calves are again weighed and feed efficiencyis calculated collectively for each group.

Statistics:

Statistical analysis of weight gain: A one-way analysis of variance isdone with classification: treatment of animals in treatment. F-tests andLSD mean separation was done using alpha=0.05 as type I error rate.Software is SAS (1999), procedure GLM.

Statistical analysis of BRD morbidity: Chi-square analysis utilizingFisher's exact test with a 0.05 or less probability interpreted assignificant is used to interpret the differences in morbidity ratesbetween groups.

Results

The results are listed in Tables A and B below.

For Group I, there were no sick pulls from the eighty head of heifersthat were treated with 1 ounce of stress formula in 1 ounce of watersolution via dosesyringe the day of processing and 1 ounce of stressformula per day added to the TMR for the four days following processing.There were 17 sick pulls and 4 repulls for BRD from the control groupwhile there were 12 sick pulls and 1 repull from the tilmicosin set.

The heifers in the Group I stress formula set had an average daily gainof 3.63 pounds for the 26 day test period, which is statisticallysignificant when compared to the other two sets. The average dailyweight gain (ADG) of the tilmicosin and control sets was 2.96 and 3.08pounds respectively. Feed efficiency for the stress formula, tilmicosinand control sets was 6.73, 6.94 and 6.66, respectively.

The heifers in the 1 ounce stress formula dosage set in Group II have anaverage daily gain of 3.2 pounds and those in the one half ounce stressformula dosage set have an average daily gain of 3.05 pounds. Thetilmicosin and control sets have an average daily gain of 2.88 poundsand 2.92 pounds, respectively. The feed efficiency for the 1 ouncestress formula is 5.31 while the values for the half ounce stressformula, the tilmicosin and the control sets are 6.09, 6.10 and 5.99.respectively.

There were 11 sick pulls and repulls for treatment of BRD in the set offifty heifers receiving 1 ounce of stress formula per day added to thetotal mixed ration for five days, beginning on the day of processingwhile there were 13 sick pulls and 4 repulls for BRD treatment in thegroup receiving % ounce TF in their TMR for five days. There were 5 sickpulls and 2 repulls from the tilmicosin set during the 30 day testperiod. Eleven BRD sick pulls and 2 repulls occurred in the control setof heifers.

Discussion:

Upon comparing the differences in the sick pull rate between the sets inGroup I, the stress formula appeared to provide significant protectionfrom BRD during the 26 day testing period. Stress formula alsosignificantly increased the average daily gain.

In Group II, the heifers in both sets achieved better weight gain thanthose in the other two sets. However, in Group II the protection fromBRD appears to be less than that of tilmicosin. When one compares theeffect of TF on BRD between Group I and Group II, the results appear tobe inconsistent until it is realized that the heifers in Group II didnot receive their initial dose of stress formula via dosesyringe duringthe processing. This evidence is a strong argument for administration ofthe initial dose via dosesyringe or capsule to assure that every subjectreceives at least the entire first dose instead of relying totally onreceiving the stress formula via the TMR. The heifers that were pulledfor treatment in the two stress formula sets may not have eaten a fullportion of the TMR on the first critical, stressful day and thereforedid not receive enough stress formula to stimulate the immune system.

When comparing the heifers receiving the full ounce per day stressformula with the set receiving a half ounce per day, there is notsignificant differences in the performance of the heifers. It is verypossible that if both dosages are administered initially via dosesyringeor capsule the differences may be even less.

It should be noted here that the value of the weight gained by thestress formula sets in excess of the weight gained by the other sets inGroup II was more than enough to compensate for the cost of treatmentsfor BRD in the stress formula sets.

In high risk cattle that are not preconditioned such as the heifers inthese studies, direct stimulation of the immune system with stressformula along with vaccine administration appeared to indeed enhance thelevel of immunity against BRD. Stress formula appeared to decrease theneed for antibiotic treatment and or enhance the effectiveness ofantibiotic therapy.

TABLE A Results for Group I 1 oz. stress formula daily - drenching thefirst day followed by 4 days of top dressing Treatment # of Feed SickGroup heifers ADG Kg (lbs) Pulls Repulls Efficiency pulls Stress 80 3.63200.0  0 0 6.73 1.65 Formula (440.1) (1 oz/day) Tilmicosin 80 2.96 200.012 1 6.94 1.35 (Micotil (440.0) 1.5 ml/cwt) Control 80 3.08 204.5 17 46.66 1.40 (449.9)

TABLE B Results for Group II Stress Formula daily - 5 days of topdressing only Treatment # of Feed Sick Group heifers ADG Kg (lbs) PullsRepulls Efficiency pulls Stress 50 3.20 200.5 11 4 5.31 1.45 Formula(441.0) (1 oz/day) Stress 50 3.05 198.8 13 4 6.09 1.39 Formula (433.0)(1/2 oz/day) Tilmicosin 50 2.88 203.2  5 2 6.10 1.31 (Micotil (447.0)1.5 ml/cwt) Control 50 2.92 196.4 11 2 5.99 1.33 (432.0)

EXAMPLE 36

A 22-year-old thoroughbred with osteomylitis and chronic laminitis ofapproximately 1,000 pounds was placed on one-ounce daily of theperformance formula as shown in column 5, Table 6 (horses) for sixmonths. He was also suffering from leaky bowel syndrome as a result ofhaving received 3 gm of butazolidin twice a day over a period of timeand had a hemoglobin of 10.9 g/dl. Upon initiation of the performanceformula, treatment with butazolidin was stopped. After two months on theperformance formula the hemoglobin rose to 14 g/dl showing theelimination of leaky bowel syndrome. After the six months on theperformance formula the horse exhibited an 80% reduction in osteomylitisand laminitis symptoms.

EXAMPLE 37

An approximately 1,000 pound, 20 year old Arabian mare was sufferingfrom fertility problems and chronic laminitis. The only way the horsewas able to stand was by administration of 500 mg of Banamine twice aday. This NSAID interfers with fertility. The horse was placed onone-ounce daily of the performance formula as shown in column 5, Table 6(horses) for 30 months and the Banamine was slowly tapered off uponinitiation of this treatment and was completely stopped after a fewweeks. At the end of 3 months there was an 80% improvement in thelaminitis. After 30 months, the laminitis was still 80% improved and thechances of conception in this mare were enhanced.

EXAMPLE 38

Splenectomies were performed on two dogs diagnosed with hemangiosarcomasof the spleen and the dogs were given six weeks to live. The first dog,a 12 years old Australian shepherd weighing 40 pounds that had beenreceiving cortisone at one mg per pound and the pain reliever Rymadal500 mg bid, was placed on three grams of the performance formula asshown in column 5, Table 6 (for dogs). Treatment of cortisone andRymadal was immediately stopped upon initiation of the performanceformula. The dog lived an additional 12 months. The second dog, a nineyear old Airdale had been on Etogesic 500 mg daily and prednisone oftwenty mg bid. The dog was placed on three grams of the performanceformula (dogs) as shown in column 5, Table 6 and treatment with Etogesicand prednisone was tapered off. After one year and three months on theperformance formula, ultrasound tests and radiographic and bloodchemistries showed no signs of hemangiosarcoma and no pain relievers orprednisone were being administered.

EXAMPLE 39

A nine year old golden retriever was diagnosed with extra skeletalosteosaarcoma with a poor prognosis of several weeks to live. Afterbeing placed on three grams of the performance formula as shown incolumn 5, Table 6 (dogs) for six months, the dog was in total remissionand had been taken off all pain relievers.

EXAMPLE 40

Three goats with carpal joint arthritis that were non responsive toBanamine and/or Butazolidine of one gram daily were placed on threegrams of the performance formula as shown in column 5, Table 6 (i.e 1000mg/oz. of transfer factor). The Banamine and Butazolidine werecompletely halted upon initiation of the performance formula treatment.After six months on the performance formula treatment all three animalsshowed an approximately 80% improvement as exhibited by reduction inswelling and increased mobility. This 80% improvement rate has continuedfor 6 months.

EXAMPLE 41

A 12 year old male Lhasa Apso was diagnosed as having acute arthritisand a deformed right front leg at the age of 10 years. The dog barelymoved all day, was unable to jump onto or off of furniture, and when hedid walk, it was very slowly and with a very pronounced limp. For oneand one-half years the dog was treated with prednisone (5 mg) every 1-2days and Glycoflex® every day. At the end of that time, the leg muscleshad atrophied and very serious arthritis symptoms remained. It was atwo-hour task to get the dog to eat each night. He was then placed onthree grams of the performance formula as shown in column 5, Table 6(dogs) mixed with his dinner each night. Within four weeks he had lostfour pounds (down to 19 from 23) and had become as active as a puppy,jumping on/off furniture, running up/down stairs and on walks, chasingsquirrels in the backyard and barking at anything that moved. The limpwas only visible upon first getting up after lying down for long periodsof time. Otherwise, the animal moved too fast for it to be noticeable.The dog had regained his appetite, emptying his bowl at every feeding,and his coat now had a shine to it. The dog has been on the performanceformula for one year and is also on prednisone (2.5 mg every third day)and Glycoflex® and, except for the very slight limp mentioned above,exhibits excellent health.

EXAMPLE 42

Feline pneumonitis is reduced dramatically by giving stress formulaorally at a rate of 5.1 gms per cup of water to infected cats. Atdifferent times, in excess of twenty cases of young kittens sufferingfrom feline pneumonitis that were not responding to a daily dosage offive mg of clavamox per pound of body weight were given 3 gm in one cupof water of the stress formula daily as shown in column 5, Table 5.Treatment with clavamox was halted upon initiation of the stress formulatreatment. After five days on the above stress formula protocol all ofthese kittens appeared symptom free of the pneumonitis.

EXAMPLE 43

A herd of cattle in Fort Bidwell, Calif. had a chronic problem with calfdysentery with a death rate of 63% and morbidity of 90%. This problemhad persisted for seven years. Treatments that resulted in noimprovement included the antibiotics tetracycline, mycotil, sulfur andpenicillium along with the other traditional treatments such as fluidsand anti-diarrheal medications like kaopectate. The University ofCalifronia, Davis, and the University of Washington were unable toprovide a solution. Forty test calves weighing around 100 pounds eachwere treated daily with one ounce of stress formula as shown in column5, Table 5 delivered in a gelatin capsule for two days and 60 calvesacting as controls received nothing for prophylaxis. In the test calvesone animal died because it had been medicated too late but none of theother test animals exhibited any symptoms of disease. However, thecontrol calves had a 90 percent rate of dysentery which was the same asin previous years. The calves were treated with stress formulaimmediately after they broke with the dysentery and they cleared up. Thenew calves in the herd are now being treated with one ounce of stressformula as shown in column 5, Table 5 in gelatin capsules and theyshowed the same results with one gel cap daily for two days as the testcalves. The last twenty calves in the herd that have been treated withthe stress formula protocol have been turned out to pasture and are 7%heavier and have better coats and attitude than the test calves.Neighboring ranchers with calves having similar dysentery problems havealso started testing the stress formula protocol and have obtainedsimilar successful results.

EXAMPLE 44

A farm in Pennsylvania had 40 ovum donor cows that were losing all theircalves and some of the adult cows also appeared ill. The University ofOhio diagnosed the cows and calves as suffering from ClostridiumPerfrengens type A. The cows and calves were first treated with severalavailable antibiotics with no success. The morbidity rate for the calveswas 100% and mortality was 80%. A protocol was begun of treating calvesweighing about 80-100 pounds each with one ounce daily of the stressformula as shown in column 5, Table 5 for seven days when they wereborn. These calves were given no antibiotics. Since the initiation ofthis protocol approximately 30 calves have been treated, no dysenteryhas been observed in the herd and no more calves have died.

EXAMPLE 45

A herd of 130 head of cows and calves in Columbus Nebr. was sufferingfrom chronic dysentery of coliform origin. Approximately 60% of thecalves appeared affected. Treatment with antibiotics and fluids providedmoderate success with an approximate ten percent mortality rate. Ten ofthe calves weighing about 80-100 pounds each and suffering from thedysentery were then treated daily with one ounce of the stress formulaas shown in column 5, Table 5 for three days. After the three days onthe protocol the 10 calves no longer exhibited signs of dysentery.However, the untreated calves still had dysentery problems.

EXAMPLE 46

Fifty mares and foals at a farm in Yakama Wash. were infected withRhodococcus. The foals were treated with Azithomycin daily from birthfor six weeks along with a plasma infusion at birth and again at 14days. A study was conducted in which twenty-five foals weighingapproximately 110 pounds each were drenched with one ounce of the stressformula as shown in column 5, Table 5 from several hours old for sevendays and twenty-five foals that did not receive the stress formulaserved as controls. The Azithomycin and plasma treatments were haltedimmediately upon initiation of the stress formula in the animalsreceiving that formula. The Azithomycin treatment was maintained for thecontrols. The foals that were drenched with stress formula had anaverage white blood count of 13,000 at 24 hours of age. The controls hadan average of 8,000, indicating a much higher level of immune readinessfor the stress formula foals. The stress formula treated foals exhibiteda 63% increase in white cell count. The foals were weighed weekly andthe test foals were consistently heavier. One case of joint illness andthree cases of respiratory problems were observed in the controls aftertwo weeks into the study. No problems were observed with the test foals.

Table C below sets forth the results of a blood test that showed thatthe administered stress formula and not the elevated response was due tothe colostrum from the mare. Usually most of the mare colostrom is nolonger absorbed by a foal after 12 hours. This test showed a 63%increase in white count.

TABLE C BLOOD DRAWN BLOOD DRAWN AT BIRTH AFTER 28 HOURS WBC 5.7 9.3 HCT41.1 27.6 BASOPHILS 0 0 EOSINOPHILS 11 0 POLY 4220 7347 LYMPHOCYTESLYMPHOCYTES 1340 1767 MONOCYTES 129 196 FIBRINOGEN 200 200

EXAMPLE 47

This study with 300 pigeons shows that the addition of 5.61 gms ofstress formula as shown in column 5, Table 5 per of gallon of drinkingwater per day for seven days dramatically reduced the incidence of circovirus in pigeons. The dosage was given in drinking water and or mixed infood with a moist carrier to 300 pigeons and was consumed by the pigeonsin twelve hours. A n average pigeon weighs about 300 gm and the waterconsumption of a pigeon is about 40 ml per day. Thus each pigeonreceived dosage of about 1.25 mg of transfer factor in stress formuladaily for seven days. After seven days the incidence of circo virus inthe 300 pigeons was reduced 40%.

EXAMPLE 48

An 18 year old male pony weighing 500 pounds that was fed 1500 mg ofstraight Transfer factor in wheat bran for three months showed a lowthyroid reading of 9.87 fig and a poor cortisol rhythm of 5%. Afterreceiving 1500 mg of transfer factor, essential fats (20571.88 mg ofcanola oil, 20571.88 mg of safflower oil and 1,418.75 mg of flax seedoil as shown in Table 2) and 498.72 mg of zinc daily for 8 months, thethyroid level was increased 43% to 14.6 μg and cortisol function wasraised to 59%. This shows the synergism of transfer factor, zinc andessential fats in treating hypothyroidism.

EXAMPLE 49

A 20 year old female mare weighing 1000 pounds exhibited a low thyroidreading of 0.9 ug/dl (with 0.9 ug to 2.8 ug being normal) and aninconsistent cortisol rhythm. After being given 1500 mg of transferfactor in a bran carrier for 20 days a second reading at a different labwas taken which showed a thyroid level of 5.6 ng (with 12.0 to 40.0 ngbeing normal) and a morning cortisol rhythm of 44.7 ng and evening oneof 43.6 ng. The horse was then put on 1500 mg of transfer factor withessential fats (20571.88 mg of canola oil, 20571.88 mg of safflower oiland 1,418.75 mg of flax seed oil as shown in Table 2) and 498.72 mg ofzinc daily for two months and 10 days. After that time, the blood teststaken showed a 78.5% increase in thyroid function to 11.0 ng andcortisol rhythm improvement from 2% to 51% in normal ranges withreadings of 69.8 ng in the morning and 34.3 ng in the evening. The horsehas been maintained on this transfer factor, essential fats and zincregimen and has shown continued clinical improvement with hoof and haircoat indicative of good thyroid function.

EXAMPLE 50

An 8 year old warm blood horse weighing 1200 pounds and suffering fromEPM had been on 3000 mg of transfer factor for six weeks with histraditional diet and had shown no clinical improvement. After beingadministered 5 oz of the premix formula (as shown in column 5, Table 2,except that the amount of transfer factor was 1500 mg instead of 750 mg)daily for 35 days this horse improved 80%. This horse is now beingmaintained daily on 5 oz of the Premix formula as shown in column 5,Table 2 except that the amount of transfer factor was increased to 1500mg and has continued to improve.

EXAMPLE 51

Over fifty cases of benign tumors in cats (2.2 gm/daily as shown incolumn 5, Table 4), dogs (28.37 gm/daily as shown in column 5, Table 3)and horses and cattle (5 oz./daily as shown in column 5, Table 2) havebeen treated with the premix formulations. These tumors range frombenign sarcoids, to pappilomas. In general, the tumors have been reducedfrom 40% to 80% and and even completely in some cases. Malignant tumorssuch as oral squamous cell carcinomas have been reduced in dogsreceiving 28.37 gm/daily of the premix formula as shown in column 5 ofTable 3 and in cats receiving 2.2 gm/daily of the premix formula asshown in column 5 of Table 4.

EXAMPLE 52

An outbreak of PURRS (porcine upper respiratory and reproductive diseasein swine) occurred at a swine operation located in Iowa. The outbreakaffected thousands of pigs with high mortality and morbidity rate. A setof 6200 pigs, weighing about 12 pounds each, that had just arrived fromthe farrowing house were dosed daily with 130 g total of transfer factorin 2.86 gms or 0.1 oz of stress formula for four consecutive days in anadvanced water metering device. The concentration of the components arethe same as shown in column 5, Table 5 except that the concentration ofdextrose is 20,825 mg and transfer factor is 1300 mg per ounce offormula. The product was suspended in solution to insure that each pigreceived an accurate dose when drinking. After 10 days on this protocolall the pigs appeared normal with no indication of PURRS.

EXAMPLE 53

This study involves 132 pigs entering the nursery at a swine farm inOhio. Sixty-six pigs weighing about 12 pounds each acting as the testgroup are dosed daily with 300 mg total of transfer factor in divideddoses of 150 mg am and pm daily in 0.15 oz or 4.2 gms of stress formulahaving the same component concentrations as the stress formula inExample 52 for three days. The remaining 66 pigs were the control groupand received no medication (antibiotics, stress formula etc.). All thepigs were fed the same diet. After 14 days the test pigs appeareddisease free and exhibited better weight gain than the control pigs.Upon slaughter the carcass data shows no liver and kidney disease in thetest group but around a 1.5% disease rate in the control group.

EXAMPLE 54

A five year old gelding, weighing about 1000 pound, has chroniclaminitis with 5 degree rotation of p-3. This horse is on oat hay andtwo grams of Butazolidin twice daily, with constant episodes of acuteinflammation, ulcerations in the gastrointestinal tract and anemia.Hemoglobin is 11.0 percent. The horse is administered 1500 mg oftransfer factor and super oxide dismutase at 6.0 mg per pound of bodyweight daily for two months. After this time, there is a 50% reductionin the laminitis with a 12% hemoglobin elevation and butazoldin isreduced to one half gram twice daily. The horse no longer appears anemicand has a bright coat and attitude. The ulcerations in thegastrointestinal tract appear healed.

EXAMPLE 55

A fifteen year old horse male, weighing 1000 pounds, with laminitis forfive years, re-occurring episodes of inflammation and gastrointestinalulcerations is given two grams of butazoldin twice daily to controlthese symptoms. This horse is lame to the extent she is not serviceablysound. The horse is then given a daily treatment of 1500 mg transferfactor and glucosamine salts at a rate of 6.5 mg per pound of bodyweight for three months. This allows in a reduction of the butazolidinto one half gram twice daily and reduces the ulcerations from the leakygut syndrome. This horse is 40% improved and capable of light groundpleasure work.

EXAMPLE 56

A ten-year-old mare weighing 1000 pounds, with chronic laminitis is ahigh level performance horse with slight rotation of p-3. She requiresone-half gram of banamine twice daily to perform, is listless and notwinning her barrel races and has a poor hoof growth and poor hair coat.The daily administration of transfer factor at 1500 mg along with superoxide dismutase at 6 mg per pound of body weight and 6.5 mg ofglucosamine salts per pound of body weight for three months allows thereduction of banamine to 500 mg daily. The leaky gut syndrome symptomsare reduced and this horse is more alert. The horse's performance is 70%improved, and coat and hoof condition is also improved.

EXAMPLE 57

A ten-year-old dog weighing 60 pounds is recovering from surgery on hiscruciate ligament repair. This dog has additional hip dysplasia orarthritis of the hip allowing for a very poor recovery period since thisdog is on 300 mg of Rymadal daily creating kidney problems and anemiaover a five day period of time. Predinisilone at 10 mg/twice daily isdepressing the appetite. The administration of 3 grams of transferfactor (dogs) and super oxide dismutase for 21 days with a componentconcentration as listed in column 5, Table 6, allows for a 10% reductionof Rymadal and predinisilone per day with complete stoppage after 10days. After 10 days on TF and SOD, the tissue appears healed and thedog's locomotion is 80% improved and his appetite is good.

EXAMPLE 58

One hundred head of cattle weighing 450 pounds arrive in the feedlotfrom a two-hour truck ride from a ranch and are just weaned off thecows. Fifty of the cattle vaccinated are processed with routinevaccination and worming and one injection of Micotil and act a controls.The other fifty cattle are vaccinated, wormed and each given one ounceof solution containing 1500 mg transfer factor and 1418 mg of lacticacid producing bacteria as shown in Table 5. This dose is given orallyto each of the test cattle for four more days. After 30 days on thetransfer factor and lactic acid producing bacteria, the test cattle areeach 10 pounds heavier than the Micotil cattle.

EXAMPLE 59

Ten kittens are suffering from severe feline pneumonitis. Administrationof 234 mg of transfer factor and 255.9 mg of lactic acid producingbacteria as shown in Table 5 for 5 days reduces the feline pneumonitis60%.

EXAMPLE 60

A small horse ranch had a chronic problem of Rhodococcus in all of itsfoals which weigh about 110 pounds each. Traditional treatment ofplasma, azithomycin controls about 60% of the problem. The foals aregiven 1300 mg of transfer factor and 1418 mg of lactobacillusacidophilus as shown in Table 5 daily. This reduces the incidence ofRhodococcus to 20% given adjunctively with plasma azithomycin.

EXAMPLE 61

Ten foals are given the transfer factor and lactobacilllus acidophilusas in Example 60 but without the azithomycin for 5 days following birth.The incidence of Rhodococcus is reduced 60%.

EXAMPLE 62

One Hundred head of cows calving are having a serious outbreak ofClostridium Perfrengens type A with a calve morbidity rate of 80% and amortality rate of 30% given traditional treatment. The calves weighingabout 110 pounds each are given 750 mg of transfer factor and 1418 mg oflactobacillus acidophilus (109 colony forming units (CFU)/gm) for twoconsecutive days and the incidence of clostridium is reduced to 20% withmortality reduced to 5%.

EXAMPLE 63

An animal shelter has 80 sick kittens suffering from feline pneumonitis.The incidence of morbidity is 80% with 10% death. The administrationdaily of 234 mg transfer factor, 51.0 mg yeast, and 255.9 mg lactic acidfor 7 days reduces the morbidity to 30% and mortality to 5%.

EXAMPLE 64

Five hundred head of stockers enters the feed lot weighing about 600pounds each after a 6-hour trailer ride from the ranch and areimmediately processed (i.e., wormed and vaccinated). Two hundred fiftyhead or every other calf is given 750 mg transfer factor, 283 mg yeast,and 2368 mg lactic acid according to Table 5. The other calves areprocessed and some are given Micotil and others are given Liquarnycinand sulfas to test different products at recommended doses. After 40days, the transfer factor, yeast, and lactic acid bacteria calves are 12pounds heavier than the other calves and morbidity is 30% less in thetransfer factor, etc., calves than in the other calves. Carcass yielddata shows major improvement on the transfer factor cattle with largeribeye, less carcass waste, and higher yield.

EXAMPLE 65

Ten mares on a small ranch have 100% incidence of Rhodococcus withannual cost of $1,500 in treatment with plasma and azithomycin.Treatment with plasma and azithomycin is halted and all foals aretreated with a drench of one-ounce solution daily for 7 days containing283 mg yeast, and 1418 mg lactic acid producing bacteria as shown incolumn 5, Table 5, with 1300 mg of transfer factor. If any foal showsslight signs of infection it is again drenched daily for 7 more dayswith the transfer factor, yeast and lactic acid producing composition.The foals weigh about 110 pounds each. The incidence of Rhodococcus inthe foals is reduced 60%.

EXAMPLE 66

A small dairy herd of 100 cows has Clostridium Perfrengens type Achronic dysentery in its first born calves. Calves are being lost withconventional treatment. The remaining calves are treated with formula aof 1300 mg transfer factor and 1418 mg lactic acid producing bacteriaand 283 mg yeast as shown in Table 5 daily for 5 days after birth,mixing the product into solution and drenching each calf. Morbidity isreduced 60% and mortality reduced 80%.

EXAMPLE 67

A pig farm has a serious outbreak of PURRS disease affecting 60% of the5000 pig operation. The pigs have many other diseases as a result of thecomplexity of the PURRS disease. Five thousand new pigs are scheduled toarrive in one week. Each pig is given a 2.8 gm solution containing 130mg of transfer factor, 283 mg yeast and 1418 mg lactic acid producingbacteria (as shown in Table 5) before they leave the mother. Thistreatment is continued for 3 more days after they reach the nursery. Atthe end of this protocol, morbidity from PURRS is reduced 20%.

1. A formulation comprising pharmaceutically acceptable transfer factor, zinc, at least one pharmaceutically acceptable essential fatty acid, Vitamin C and a pharmaceutically acceptable yeast, wherein the amount of said transfer factor is from 10 mg to 10,000 mg per ounce of formulation.
 2. The formulation of claim 1 further comprising pharmaceutically acceptable ionic salts or chelates of one or more of calcium, phosphorous, selenium, iron, magnesium, manganese, copper, iodine, cobalt and molybdenum.
 3. The formulation of claim 2 further comprising pharmaceutically acceptable lactic acid generating bacteria, montmorillonite and Vitamins A, B₂, B₆, B₁₂, E and K.
 4. The formulation of claim 3 further comprising pharmaceutically acceptable d-biotin, folic acid, niacin, Vitamin D₃, pantothenic acid and thiamine.
 5. The formulation of claim 4 further comprising pharmaceuticafly acceptable lysine, methionine, arginine and methyl sulfonyl methane.
 6. A formulation comprising pharmaceutically acceptable transfer factor and a pharmaceutically acceptable lactic acid generating bacteria wherein the amount of said transfer factor is from 10 mg to 10,000 mg per ounce of formulation.
 7. The formulation of claim 6 further comprising pharmaceutically acceptable yeast.
 8. The formulation of claim 7 further comprising pharmaceutically aeceptable montmorillinite.
 9. The formulation of claim 8 further comprising at least one essential pharmaceutically acceptable fatty acid, pharmaceutically acceptable ionic salts or chelates of the elements calcium, phosphorous, selenium, iron, magnesium, manganese, copper, iodine, cobalt and molybdenum, yeast, Vitamins A, B₂, B₆, B₁₂, C, B and K, d-biotin, folic acid, niacin, Vitamin D3, pantothenic acid and thiamine, lysine, methionine, arginine and methyl sulfonyl methane.
 10. The formulation of claim 6 further comprising pharmaceutically acceptable ionic salts or chelates of calcium, magnesium, sodium and potassium.
 11. The formulation of claim 10 further comprising pharmaceutically acceptable citric acid.
 12. The formulation of claim 11 further comprising Vitamins A, B₂, B₆, B₁₂ C, E and thiamine.
 13. The formulation of claim 7 further comprising pharmaceutically acceptable ionic salts or chelates of calcium, magnesium, sodium and potassium.
 14. The formulation of claim 13 further comprising pharmaceutically acceptable citric acid.
 15. The formulation of claim 14 further comprising Vitamins A, B₂, B₆, B₁₂ C, E and thiamine. 